Ostavi Hydrophilic Guidewire

FDA-Cleared Indications

• Used to facilitate the placement and navigation of compatible catheters during diagnostic and interventional procedures.
• Intended for use within the vascular system when catheter advancement or positioning requires guidewire support.

Clinical Applications

• Catheter navigation during peripheral vascular angiography and intervention
• Catheter positioning during neurovascular procedures
• Guidewire-assisted catheter placement in tortuous or difficult vascular anatomy

Reported off-label uses

• Guidewire assistance during uterine artery embolization
• Guidewire assistance during endoscopic retrograde cholangiopancreatography

Off-label use: these uses are reported in practice or the literature but are not part of the FDA-cleared indications. Physicians may use a cleared device off-label based on their medical judgment; the manufacturer may not promote off-label uses.

Practical Considerations

• Select the wire diameter, length, tip configuration and stiffness that match the catheter, access route and target anatomy.
• Use under appropriate fluoroscopic or other image guidance, with a compatible catheter and continuous awareness of the wire tip position.
• Hydrophilic coatings become lubricious when wetted; follow the device instructions for preparation, flushing and handling.
• Do not advance or withdraw the wire against significant resistance. Vessel injury, dissection, perforation, thrombosis or embolization can occur.
• MRI safety and conditional-use information should be confirmed in the current manufacturer labeling before MRI exposure; do not assume that a retained or implanted guidewire is MRI safe.